Importing medicines into Iraq

The regulator

Medicines in Iraq are regulated by the federal Ministry of Health. A 2021 report in the WHO Eastern Mediterranean Health Journal describes the structure. The Directorate of Technical Affairs is the main regulator, with a Registration Department for products and companies and a Pharmacy Department that issues import licences. The National Center for Drug Control and Research, part of the same directorate, tests medicines before registration and before batches are released. Kimadia, the state company for marketing drugs and medical appliances, procures and distributes medicines for public hospitals and primary care. A 2025 legal handbook refers to an Iraq Drug Regulatory Authority within the Ministry, a name that should be confirmed with the Ministry.

The Kurdistan Region has its own Ministry of Health. Its Kurdistan Medicines Control Agency (KMCA) registers products, sets private sector prices and checks medicines at the region's border crossings, while Kimadia still supplies public facilities there.

Legal routes for unregistered medicines

Iraq's system is built around registration. According to the US commercial guide for Iraq and the WHO regional report, the manufacturer and the product must be registered with the Ministry of Health, and an import licence is issued for each consignment to the private sector. At customs, release depends on a registered manufacturing site, listing in the national essential medicines list and a passed quality test, with some exceptions for FDA or EMA approved products.

Fast-track temporary registration

Since February 2019 a fast-track route has given urgently needed medicines approved by credible regulators, such as the FDA or EMA, temporary registration and an import licence within about one month. It needs seven documents, including a CPP, composition, analytical methods, stability data, a price certificate and samples. The regular route was reported to take about a year.

Public procurement through Kimadia

Kimadia imports for the public sector through tenders, and each tender lists the documents required. When Kimadia cannot secure an essential medicine, provincial health directorates may procure it from the private sector. This is the usual channel for hospital needs in the public system.

Exceptional and named-patient imports

No published Ministry of Health guideline was found for importing an unregistered medicine for a named patient. Some third-party guides describe such a route, but it could not be confirmed from an official source. The Ministry has also stepped up action against smuggled medicines, including a June 2025 meeting on smuggled medicines, so shipments outside the licensed channels carry real risk. Any exceptional import should be agreed in writing with the Directorate of Technical Affairs or Kimadia before the goods ship.

Documents a buyer usually needs

• Ministry of Health import licence for the consignment, or KMCA approval in the Kurdistan Region
• Registration of the manufacturer and the product, or fast-track temporary registration
• Letter from the manufacturer approving export of the product to Iraq
• Certificate of pharmaceutical product and GMP certificate, legalised where required
• Commercial invoice, packing list and certificate of origin
• Certificate of analysis for each batch
• Air waybill
• Written request from the hospital, health directorate or Kimadia for any exceptional import

Timeline: a worked example

A teaching hospital in Baghdad needs a specialty medicine that is approved by the FDA but not registered in Iraq, and the supplier's scientific bureau uses the fast-track route.

Total: roughly 2 to 4 months from request to delivery. These are planning estimates, not published service times.

Shipping lanes from India

Most freight from Delhi, Mumbai or Hyderabad to Baghdad (BGW), Basra (BSR), Najaf (NJF) or Erbil (EBL) connects through Dubai, Doha, Istanbul or Amman. Nonstop services have been limited, for example a SpiceJet service to Najaf scheduled from October 2025 to March 2026. Express courier service is usually 4 to 8 days door to door for registered, non-controlled products. Air cargo is usually 7 to 14 days including customs and any quality testing.

CIP and DAP to the Iraqi importer are the usual terms, and FCA suits importers with their own forwarder. DDP is rarely practical because the Iraqi scientific bureau or Kimadia holds the import licence and clears the goods.

Practical tips for buyers

• Decide early whether the product will enter federal Iraq, the Kurdistan Region or both, because KMCA registration builds on the federal decision but is a separate step.
• Ask the scientific bureau to confirm that the product is registered and on the essential medicines list before quoting delivery dates.
• The Council of Ministers exempted imported medicines from customs duty from 7 October 2026, according to press reports. Before that, customs said medicines carried 0.5 percent duty and vitamins 5 or 10 percent. Iraq has no general VAT.
• Customs alone decides whether a product is a medicine for tariff purposes, and a Ministry of Health approval does not settle that, so check the HS code with a customs agent.
• Keep documents legalised and consistent. The 2021 WHO regional report described most Ministry document handling as paper based, and mismatches add weeks.